Roche, a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics, has expanded HIV Global Access Programme to include early infant HIV diagnostic testing for low and middle income countries.

Roche, in partnership with the Joint United Nations Programme on HIV/AIDS (UNAIDS), the Clinton Health Access Initiative (CHAI), UNITAID, the US President’s Emergency Plan For AIDS Relief (PEPFAR) and the Global Fund to fight AIDS, TB and Malaria, is committed to working with the Diagnostics Access Initiative by providing state-of-the-art solutions to achieve the 90-90-90 goal set forth by UNAIDS. Announced in 2014, the HIV Global Access Programme is Roche’s most recent addition to the AmpliCare Initiative, launched in 2002 in South Africa.

“As the leader in HIV diagnostics, Roche is proud to support the UNAIDS 90-90-90 goal by expanding access to quality HIV testing for early infant diagnosis in resource limited settings,” stated Roland Diggelmann, chief operating officer of Roche Diagnostics.

“Increased access to early infant diagnosis can provide an impactful contribution for mother and child and contribute to achieving UNAIDS’ goals for controlling and eradicating the HIV/AIDS epidemic.”

By expanding the Global Access Programme for HIV, Roche is providing its dual-target COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test version 2.0 through an affordable price offering for qualifying organisations in 82 eligible countries with the highest disease burden. The test provides a simple, innovative method for collecting, transporting and storing patient samples in resource-limited settings. The HIV-1 dual-target qualitative test drastically reduces the volume of blood required for testing, while dramatically reducing stress for the mother and the child. Timely HIV infant diagnostics are required for antiretroviral treatment to save the lives of HIV-infected babies across many African countries.

“This agreement with Roche Diagnostics is a powerful step towards ending the unconscionable failure of the world to meet the treatment needs of children living with HIV,” said UNAIDS executive director Michel Sidibé. “We now need to use this agreement to rapidly scale up diagnostic and treatment services for all children living with HIV, in line with the 90-90-90 target.”

“This collaboration illustrates how we are sharing responsibility and working together to end the HIV/AIDS pandemic,” said ambassador Deborah L. Birx, M.D., US Global AIDS Coordinator and US representative for Global Health Diplomacy. “The US President’s Emergency Plan for AIDS Relief (PEPFAR) is scaling up our efforts to identify, test, and treat children living with HIV/AIDS and Roche’s decision to include early infant HIV diagnostic testing in the HIV Global Access Programme will have a considerable impact—helping PEPFAR expand the reach of our investment.”

“This agreement builds on and supports other efforts of a strong partnership to make the market for viral load testing more competitive and transparent, and that better serves children affected by HIV,” said Mark Dybul, executive director of the Global Fund.

“This agreement will allow more children to be tested and enter treatment sooner saving many lives,” said CHAI chief executive officer Ira C. Magaziner. “I congratulate Roche. This represents the latest in a series of agreements where Roche has been a pioneer in bringing state of the art testing to resource poor settings at affordable prices.”

Roche announced in 2014, the Global Access Programme for increased access to HIV viral load as an addition to the AmpliCare Initiative, which launched in 2002 in South Africa. Roche partnered with national governments, local healthcare facilities, communities and international agencies, including CHAI and Centres for Disease Control (CDC), to establish programmes that would go beyond providing diagnostic tests. The AmpliCare Initiative was a proactive response to the enormous humanitarian challenge of HIV/AIDS and TB. Since its inception, the programme has increased access to HIV viral load tests at substantially reduced prices in sub-Saharan Africa and countries where the disease burden is highest.

Diagnosing HIV in infants and young children is a major challenge. Antibody tests are ineffective in children because the mother’s antibodies remain in the child’s system following birth. In fact, antibody tests in infants may yield false positive results for up to 15 months. There are a number of alternate methods available for early diagnosis of HIV infected infants. Many approaches use molecular techniques, specifically detecting the viral DNA and/or RNA, which enables HIV diagnosis in less than six weeks.

Early diagnosis is critical for children infected with HIV. If found HIV positive, they can receive appropriate medical care before they develop significant illness, and can remain healthy despite their infection. If found HIV negative, the mother can get appropriate counseling to ensure their child maintains a HIV-free status.

The COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 is an in vitro diagnostic, total nucleic acid amplification test for the qualitative detection of Human Immunodeficiency Virus Type 1 (HIV-1) DNA and RNA (or total nucleic acid, TNA) in human plasma or dried blood spots using the COBAS AmpliPrep Instrument for automated specimen processing and the COBAS TaqMan Analyser or COBAS TaqMan 48 Analyser for automated amplification and detection. The dual-target test is designed for broad HIV-1 detection in the presence of naturally-occurring and drug-induced mutations.

The test is a diagnostic test, indicated for individuals who are suspected to be actively infected with HIV-1. Detection of HIV-1 TNA is indicative of active HIV infection. Infants born to mothers infected with HIV-1 may have maternal antibodies to HIV-1, and the presence of HIV-1 nucleic acid in the infant indicates active HIV-1 infection. In adults, the test may be used as an aid in the diagnosis of HIV-1 infection.

Accordingly to the World Health Organisation (WHO), there were 35 million people including 3.2 million children under 15 living with HIV around the world in 2013. That same year 2.1 million people, including 240,000 children under 15 years, became newly infected with HIV worldwide. For the most impacted region of Sub-Saharan Africa nearly 1 in every 20 adults of all people living in this region are HIV positive.

The transmission of HIV from an HIV-positive mother to her child during pregnancy, labour, delivery or breastfeeding is called vertical or mother-to-child transmission (MTCT). In the absence of any interventions HIV transmission rates are between 15-45 per cent.

Accurate diagnosis, highly active antiretroviral treatment (HAART) and viral load testing, a test to determine the amount of circulating HIV, have contributed to a steady increase in life expectancy for HIV infected people of 13 years.